Note: Descriptions are shown in the official language in which they were submitted.
~ 38~
~g57-270
The present invention relates to tuhing for u.5e in an
intravenous flow controller and more specifically to a novel flo~,
controller.
Controllers for controllincJ the drop or flow rate
through an intravenous tube are well known in the art and are
exemplified by devices i:llustrated in United States Patent ~los.
3,991,972, 4,137,940 and ~,300,552. The forces required of such
devices to completely block flo~7 through the standard round I.V.
tube are ~ypically as much as three pounds. Only a relatively
~mall amount of the force is required to close the main body of
the tube, the majority of the force being required to close small
cir~ular openings at the outer edges of the compressed tube, a
phenomenon commonly known as the dog-bone effect. The high
pressure required to close round tubing will deform the tube wall.
Upon release of the pressure, during initial fluid flow, the
deforma~ion in the tube wall requires time to return to its
original thickness. This element of time undesirably affects tne
response time of the control device. In addition, due to the high
forces required to fully close the round tubing, when pressure is
released the tubing will have a tendency to stick together.
SUMMARY OF_THE PRESENT INVENTION
The invention provides an intravenous flow rate
controller comprising: a passage means in said controller for
receiving a tube through which intravenous fluid may flow; a knife
edge means located on one side of said passage means: a wall means
projecting into said passage opposite said knife edge means; a
first spring in operative contact with said knife edge means for
~J~
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52~7-23
biasing said knife edge means into engagement ~ith said ~7all
means; a first shape-memory member in operative contact with said
knife edge means, said first shape-memory member when heated
capable of countering the force of said spring and causing said
knife edge means to move away from said wall means proportional to
the degree of heatiny of said first shape-memory member; and brake
means operatively connected to sald knife edge means for locking
said knife edge means with respect to said ~all means and
countering the force of said spring when said first shape-memory
member is unheated to main~ain precise positioning of said knife
edge means with respect to said wall means.
The flow rate controller uses a flow control tube in the
~orm of an intravenous tube of a novel configuration to reduce by
as much as 90% the force re~uired to close the tube. The novel
control mechanism designed to take advantage of the improvements
provided by the novel tube configuration.
The tube may be formed from an initially round plastic
tube of suitable material such as polyvinylchloride which has a
diameter and wall thickness that is standard for the industry;
approximately .143 inch O.D., and .105 inch I.D., thus providing a
wall thickness of approximately .019 inch. According to the
method employed to form the tube, a mandrel is inserted in such
tubing and this length of tube surrounding the mandrel is heated
in a mold to produce an internal cross-section defined by
symmetrical
~ 2 ~
catenary shaped wall portions terminating in opposed
sharp internal corners which looks like the opening
of the eye when the lids are open or even like an
oyster shell with a slightly larger heigh~ than
average. Thus, the interior of the wall portions of
the tube come together in sharp corners and curve
outwardl~ to meet in a gentle curve in the middle of
~he wall portions. When the ~pposing wall portions
of the opening are moved toward one another the
opening flattens out with no dog-bone effect and the
forces reguired ~o close the tube are greatly
reduced.
It is within the scope of the invention to
form the finished tube of the present invention by
methods other than reforming a round tube. Specific-
ally, the novel flow control tube may be formed by
precision extrusion, lamination or blow molding
techniques as well as other methods of forming a
tubing having a dimensionally precise cross-section.
The wall thickness of the finished tube of
the example is important since it must be ~hick
enough to have sufficient resilient force to open in
spite of ~he hydrostatic forces tendin~ to hold the
opp~sing interior surfaces of the plastic together
a~ter the tube has been completely collapsed. If the
walls are ~oo thin ~hey tend to adhere to one ano~her
and are slow to open, requiring hydrostatic pressure
build-up to reopen the tube.
On the other hand, the wall~ of the recon-
figured tube ~hould not be so thick that large forces
are re~uired t~ move the wall~ of the tube, ~hus
:~2~588~
increasing response time and requiring a controller
capable of delivering much greater forces and rapid
response. In the present invention, a final wall
thickness of the reconfigured tube is about .015 inch
with an interior length of opening of about .142 inch
with an interior height of about .06 inch. Such a
~ube requires a force of about 1/2 pound to stop flow
whereas a round tube of the same material reguires
about 3 pounds to fully close.
The specific size and precise shape of a
reconfigured tube is a function of the initial tube
diameter, wall thickness, tube material and ~he
liquid to be controlled. The example given above and
described in greater detail hereinaft~r is intended
to ~e considered only as exemplary of a specific
tube.
The tube is reconfigured by inserting a
mandrel of the desired final shape and size into the
tube, compressing the exterior of the tube in a mold
and heating the mold and tube to produce a perma-
nently reconfigured shape.
The controller of the present invention
utiliæes a relatively sharp edge on one end of a
right-angle lever to compress the reconfigured tube.
The lever is actuated by a shape-memury alloy
element, preferably in the form of Nitinol wire, ~nd
a brake mechanism is provided which can lock ~he
lever in a de~ired fixed position. The brake may
al~o be Nitlnol-controlled.
~75~38~
~J7-~39
The controller is configured such that the sharp edge of
the lever engages the tube at right anqles to an opposing tube-
abutting surface ~hen the tuhe is fully closed, such operation
being possible due to the relatively small width of the
reconfigured tube. Such operation insures complete closing with
the least amount of force for a given system.
Also disclosed is a method of changing the configuration
of a flexible plastic tube comprising the steps of:
~88
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inserting a mandrel of the desired internal
cross-sectional shape into the tube;
clamping at least a portion of the region of
said ~ube into whi~h the mandrel has been inserted in
a clamp having opposed surfaces which define an
interior cavity having approximately the same ~hape
as the cro-~s-section of the mandrel;
heating the mold to a temperature and for a
time to cause reflow of the material of ~he tube; and
removin~ the tube from the mold and ~he
mandrel from the tube.
BRIE:F DESCRIPTION_OF THE_ DRAWINGS
Figure 1 is a side view in elevation of a
mold employed to form the tube of the present
invention.
~ igure 2 is a side view in elevation of the
mandrel employed to mold the tube of the invention.
~ igure 3 is a top view of the mandrel.
~ igure 4 is a view in cross-section of the
mandrel taken along line 4-4 of ~igure 3.
Figure 5 is a view in cross-section of the
tube of the present invention positioned within the
mold of ~igure 1.
Figure 6 is a front view in elevation sf the
c~ntroller of the present invention.
~275884
--7--
Figure 7 is a ~ection view of the controller
of Figure 6 taken along lines 6-6 of Figure 6.
Figure 8 is a detailed enlarged cross-
sectional view of a part of the bushing and brake rod
of Figure 6.
Figure 9 i~ a graph of force-vs-length
curves for Nitinol at ~elected temperatures ~n the
transformation temperature ra~ge.
DETAILED DESCRIPTION OF THE INVE~TION
Referring specifically to Figures l, 2, 3
and 4 there is illustrated the mold (Figure 1) and
mandrel (Figure 2) required to produce the flow
control tube of Figure 5.
The mold comprises a pair of aluminum bl~cks
2 and 4 which have opposed surfaces 6 and 8 machined
to provide matching relieved surfaces. Each surface
has regions 10 and 12 on either side of center of a
machined-out depth of about .012 inch, thus providing
a space therebetween of .024 inch when the blocks are
clamped to~ether unless shims are employed as
hereinaf~er explained. Centrally located between the
ends of regions lO and 12 ~f each block is a gener-
ally arcuate region 14 of increased height. The
length of each region 14 is abou~ .175 inch and the
depth perpendicular to the page i~ approximately 0.44
inch. The bl~cks may be clamped ~gether by two
~olt~ 16 and 180 having their heads ~eated in block 2
and threaded into block 4.
~2'75~384
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To~ling also includes a mandrel 20, as
illlustrated in Figures 2 and 3, which is to be
inserted into the tube prior to clamping in the mold.
The mandrel in this example has a width of approxi-
mately .142 inch, a maximum thickness of .06 inch, a
radius at its end region 24 of .083 inch and inter-
secting at points 26 at the two ends.
~ ody 28 of the mandrel 20 is tapered alon~
both edges 30 and rounded at its corners 32 to permit
ease of insertion into the tube.
In operation the mandrel 20 is inserted into
one end of a length of plastic tubing and the tubing
is clamped between the blocks 2 and 4. The blocks
are ~hen heated to about 200C for a short time such
as about ~ to 3 minutes to reflow the polyvinyl-
chloride, producing the shape of tube 30 illustrated
in Figure 5 of the accompanying drawings. It can be
seen that the generally continuous sidewall of the
hollow elongated tube has an internal cross-section
defined by symmetrical caternary shaped wall portions
terminating in opposed sharp internal corners 38~
The mandrel 20 has an external cross-section comple-
mentary to the finished tu~e shape. The regi~ns of
the tube that are clamped between regions 10 and 12
of ~he blocks are fused together to produce end
regions 32 and 34. The tubing disp~sed about the
mandxel 20 is configured in a caternary ~hape as at
36 with a center region having an internal radius R1
for each wall portion of about .OS2 inch and the end
regions havin~ a reverse radii R2 of about .07 inch,
~uch that ~he wall portions ~oin approximately
tangentially in opposed ~harp corner~. The internal
1 Z7~i~38~
radius R1 and the reverse radii R2 are approximately
equal.
The relationship between the internal radius
and the reverse radii must be chosen to prsvide:
(1) sufficiently sharp internal radius to
provide adequate opening force;
(2) an approximate joining of the opposed
wall portions;
(3) a smooth transition between the center
region and the end regions; ~nd
(4) an internal cross-section that is
adequate for the desired f low rate.
This can be achieved when the internal
radius and the reverse radii are close to equal.
In order for a controller to close the
opening in the tube, a knife edge 62 is applied
parallel to center line 42 along one of the surfaces
of the tube over the region between points A and ~ of
Figure 5, the opposed surface of the tube abu~ing a
wall so that the tube is easily closed with low fsrce
and small movemen~ of the knife edge to m~ve the wall
p~rtions toward each o~her to flat~en the tube an~
control flow therethrGugh.
Reference is now made to-Figures 6 and 7 ~f
the acc~mpanying drawings which illustrate the
~ontroller of the present invention. The controller,
1275B84
--10-
generally designated by the reference numeral 46, has
a drop chamber cavity 48 with an opening 50 at the
b~ttom to feed one end of the tu~e of Figure S which
is secured in a channel 52 of circular cross-section,
A drop chamber assembly may be placed in cavity 48
and attached to the top end of the tube 30. The
reformed region 36 of tube 30 is situated at inward
pro~ection 54 of the left wall, ~s viewed in Figure
6, of the passage 52. The ~ivotal lever 56 has a
horizontal arm 58 and a ver~ical arm 60 terminating
in a horizontal knife edge 62 directed toward the
projection 54, all as viewed in Figure 6. The lever
56 is pivoted about a horizontal pivot pin 64
disposed relative to the wall 66 so that the knife
edge 62 may be moved toward and away from the
opposing wall 66 of the projection 54, the wall 66
projecting into the passage opposite the knife edge
Ç2. The projection 54 is re~uired to permi~ the
pivot pin 64 of the lever 56 to be located so that
the knife edge 62 lies in a plane perpendicular to
the wall 66 when in engagement with the wall to
thereby insure maximum closing force at the time of
full closure of the passage.
The tube 30 is l~cated in channel 52 such
that the region 36 of the tube lies between the wall
66 and the knife edge whereby movement of the lever
56 ca~ses the knife edge 62 to close ~he tube to
varyin~ degrees depending upon the desired drop rate.
Control of the lever 56 is accomplished by a
wire ~8, hereinafter the 'first shape-memory member",
of ~hape-mem~ry material, preferably ~itinol, which
extends from a first electrical terminal 70 downward
>
~ 2 7 S ~ ~
into operative contact with the lever 56 under a
horizontal pin 72 extending outwardly from the arm 58
of the lever 56, and upwardly to a second electrical
terminal 74. It is, of course, within the scope of
the invention to have the first shape-memory member
be of alternate csnfiguration such as a cantilevered
lever, etc. (not shown) and in operative contact with
lever 56. Sticking out of the end of the arm 58
remote from the pin 64 is another horizontal pin 76.
The pin 76 is en~aged by a tension spring 78, herein-
after the "first spring", extending downwardly from
the pin 76 ts a spring-engaging plate 80 secured to
frame 82 of the controller 46.
First spring 78 pulls down on the pin 76 to
rotate the lever 56 clockwise to cause the knife edge
62 ~o approach wall 66 and close the tube 30, i.e. to
bias the knife edge 62 into engagement with said
wall. The Nitinol wire, when energized by passing
electrical current through the wire, thus raising the
wire's temperature by resistance heating, opposes and
counters the force of the first spring 78 to varying
degrees to control flow rate.
It is well known that, in the temperature
range where Nitinol transforms between the austenitic
and martensitic states, the alloy exhibi~s a continu-
ous variation in its mechanical properties with
temperature. In the case of a Nitinol wire wi~h
initial length Lo~ the mechanical behavior can ~e
represented by the force ~ required to elongate the
wire by a change in length L. The force-versus-
length curves for Nitinol at ~elected temperatures in
127588
- 1 2 -
the transformation temperature range (TTR) are shown
in Figure 9.
At temperature T1, the alloy is fully
mar~ensitic and can be stretched a relatively large
amount, Ll, corresponding to about 8% strain, at a
relatively low and constant force Fl. When the
Nitinol wire i~ heated without applied stress to the
austenitic state at T4, the length returns to Lo by
the shape-memory effect. At temperatures be~ween Tl
and T~ the curves change from Curve A to Curve D type
behavior and the amount of heat-recoverable strain
decreases. At T4 there is no heat~recoverable
strain. Intermediate Curves B and C corresponding to
intermediate temperatures T2 and T3 are shown in
Figure 9 as examples.
Consider a Nitinol wire which is elongated
by the applied force from a conventional elastic
spring so that the Ni~inol wire stretches as the
spring compresses and vice versa. The stress-strain
curve of ~he spring is defined by the straight line,
E.
The Nitinol, at temperature Tl, can be
stretched by the spring out to length L1. If the
Nitinol is then heated it will at~empt to recover its
strain by the shape-memory effect but must work
against the spring to do so. As the temperature
increases, the Nitinol follows the path abcd defined
by the intercepts of the ~pring ' ~ force-length ~urve,
E, which i~ e5sentially independent of temperature,
and the family of temperature-dependent Nitin~l
force-length curves, A, B, C, D.
1~75~
If the Nitinol temperature is controlled by
resistively heating the length of Nitinol wire, each
temperature T1, T2, T3, T4 corresponds to a current
I1, I2, I3, I4. Thus by varying the current and
hence the temperature, the Nitinol wire can be
precisely controlled to a corresponding length L1,
L2, L3, L4-
Although only Nitinol has been discussedherein, various changes in properties are affected by
additives, heat treatment and work hardening.
Further, Cu-Zn-Al and other copper-based and like
alloys are also specifically useful herein, having
many of the same types of characteristics as Nitinol.
See, for instance, "Shape Memory Alloys", Page 728,
Vol 20, of Kirk-Othmi's EncvcloPedia of Chemical
Technoloqy, John Wiley & Sons, Third Edition.
A further feature may be added to the
present invention. As described above, heating power
~electrical current) must be continuously applied to
maintain a given knife edge 62 position and thus a
given fluid flow rate. A further feature of the
presen~ invention is a brake means whereby the
desired knife edge position can be maintained with
power removed from the first ~hape-memory member.
This brake means may be implemented usin~ a second
shape-memory member as the actuatsr foroe so ~hat the
brake means is free when p~wer i~ applied to the
~econd ~hape-memory member and locked when power is
removed. Thls provide~ an actuator that can be
preci~ely adjusted by ~equentially removing power
fro~ the ~econd and then the fir~t ~hape-memory
~7588~
members and will maintain this precise adjustment
with no power applied to either of the shape-memory
members.
An embodiment of the brake means in the form
of a J-shaped brake rod 84 has its bottom lo~p
disposed under the pin 76 and its riser extends
upward through a passage through a cylindrical
bushing 85. The upper end of the rod 8~ has a hole
86 to receive one end of a tension spring, herein-
after "second ~pring'l, that pulls up on the rod with
a much smaller force than first spring 78 pulls down
on the pin 76 and thus he brake rod. The bushing 85
is rotatable about its cylindrical axis and has a
horizontal pin 90 extending into the cylindrical wall
of bushing 85 in a generally horizontal plane.
The bushing 85, rod 84 and pin 90 are
illustra~ed in greater detail in Figure 8. The
bushing 85 has a cylindrical aperture 92 that
slidably, but snuggly, receives the r~d 84. The tw~
ends of the aperture are tapered outwardly at 94 so
as to permit the bushing to be rotated in either
direction. When so rotated the opposed edges of the
tapers 94 of the aperture 92 enyage the rod and in
effect wedge it in plaee.
The pin 90 is engaged by a second shape-
memory member in the form of a shape-memory metal
wire la2, which again may be Nitin~l. The wire 102
extends fr~m contacts 96 and 98 located below the pin
90 and over it. When the wire i~ co~l, it may be
~tretched by a third ~pring 100 extending vertically
from the pin ~0 upwardly to ~ frame member biasing
~L~27~ 34
- 15 - 62957-230
-the pin away from the third spring 100. ~nen the wire is cooi,
the third spring 100 pulls up on the pin and locks the rod 84 in
place by rotating the cylindrical bushing 85. ~nen the wire is
heated by an electrical current, the second shape memory member in
the form of the Nitinol wire pulls down on the pin 90; the rod 84
is then free to move and is pulled up against pin 76 and thus the
brake rod will faithfully -follow movement of lever 56.
In operation, the rod 84 is held in positlon by rotation
of bushing 85, and the knife edge 62 is in contact with tubing
segment 30 which is between the knife edge and the wall 66. The
wire 102 is heated by passing a current therethrough and the rod
is released but does not move since the spring 78 is stronger than
the spring 88 and the force of the wire 68 in its elastic state.
Thereafter current is applied to the wire 68 and is adjusted so
that the upward force produced by wire 68 moves the knife edge to
a position where the drop rate in the chamber 48 is as desired.
It should be noted that -the second spring 88 maintains
the rod 84 in contact with pin 90 so that iE the wire 102 is de-
energized and then a short time later the wire 68 is deenergized
the lever is locked in its last position, the rod 84 prevents the
pin 76 from moving down and the spring 78 prevents it from moving
up. Thus, the controller may be "parked" at a particular nominal
drop rate. Such operation may be beneficial because power doesn't
have to be maintained except when readjusting the restriction and
a nominal drop rate is preferable to the danger of a
9 ~7588
-16-
radically wrong rate in a ~ituation where the current
control mechanism malfunctions.
It is within the scope of the i~vention to
employ alternate ~rake means lnot shown) such as an
electrically actuated caliper brake, a clutch plate
device, or other mechanical expedients that would be
capable of selectively locking the lever 56 when in a
preselected rotated posit.ion wi h respect to the
lever's pivot when power is removed.
Various changes and alternatives to the
above tube and controller are readily appar~nt. As
previously mentioned, the specific details of the
tube (size, wall thickness, materials, etc.) will
vary with the specific fluids with which the control-
ler is to be employed and the flow rate of the fluid.
Also such a tube configuration has utility in other
flow rate control devices, particularly in chemical
systems.
The controller is of general utility being
of use wherever a flow rate or actuator posi~ion
needs to be set or maintained at a given position for
some period of time and relatively low rates of flow
are to be controlled. ~ur~her, al~hough ~ension
springs are employed, compression springs or safety-
pin-like springs are also useful.
The molding func~ion i~ useful in small
quantities but other forming techniques may be
empl~yed.
S884
Other improvements, modifications and
embodiments will become apparent to one of ordinary
skill in the art (upon review of this disclosure).
Such improvements, modifications, and embodiments are
considered to be within the scope of this invention
as defined by the following claims.
